[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Notices]
[Pages 11118-11119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0302]


Agency Information Collection Activities; Announcement of OMB 
Approval; Guidance for Industry on Formal Meetings With Sponsors and 
Applicants for Prescriptions Drug User Fee Act Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Industry on Formal 
Meetings with Sponsors and Applicants for Prescription Drug User Fee 
Act (PDUFA) Products'' has been approved by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, October 
18, 2002 (67 FR 64390), the agency announced that the proposed 
information collection had been submitted to OMB for review and 
clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, 
and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has now 
approved the information collection and has assigned OMB control number 
0910-0429. The approval expires on February 28, 2006. A copy of the 
supporting statement for this information collection is available on 
the Internet at http://www.fda.gov/ohrms/dockets.


[[Page 11119]]


    Dated: February 28, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-5356 Filed 3-6-03; 8:45 am]
BILLING CODE 4160-01-S